BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS SIMPLICITY

    MDR report key: 24142014 · Received January 22, 2026

    Report

    Report Number
    3012236936-2026-000023
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    January 16, 2026
    Report Date
    February 20, 2026
    Manufacturer
    AMO PUERTO RICO MFG. INC.
    Product Code
    HQL
    UDI-DI
    05050474731660
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A2 AGE OR DATE OF BIRTH: UNKNOWN/NOT PROVIDED. SECTION D6A, IF IMPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. SECTION D6B, IF EXPLANTED, GIVE DATE: NOT APPLICABLE AS THE IOL WAS REMOVED AND REPLACED DURING THE SAME PROCEDURE. THEREFORE, NOT EXPLANTED. SECTION H3, DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS HAVE BEEN MADE TO OBTAIN THE MISSING INFORMATION. HOWEVER, TO DATE, IT HAS NOT BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THROUGH FOLLOW-UP THE CUSTOMER INDICATED THAT THE OPERATIVE EYE IS THE LEFT EYE. THE REPLACEMENT IOL IS A JNJ MODEL DIB00 +15.5 DIOPTER. THERE WAS NO CAPSULE TEAR, VITRECTOMY OR SUTURES REQUIRED. AND NO MEDICATION OUTSIDE THE STANDARD OF CARE. THE DOCTOR¿S NAME IS (B)(6). PATIENT¿S DATE OF BIRTH IS (B)(6). THE SUSPECT PRODUCT WAS DISCARDED (WILL NOT BE RETURNED TO JNJ). THIS CURRENT REPORT IS TO UPDATE THIS INFORMATION. SECTION A2, DATE OF BIRTH: (B)(6). SECTION E1, CONTACT TITLE, FIRST AND LAST NAME: (B)(6). SECTION H6, TYPE OF INVESTIGATION: 4115-DEVICE DISCARDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS SCRATCHED FROM THE PLUNGER/INJECTOR. THE ISSUE WAS NOTICED AFTER THE LENS WAS IMPLANTED. THE DOCTOR CUT OUT THE IOL AND REPLACED IT WITH MODEL DIB00 15.5 DIOPTER. IT IS UNKNOWN IF THE PATIENT OR USER WAS HARMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204247 TECNIS SIMPLICITY INTRAOCULAR LENS HQL AMO PUERTO RICO MFG. INC. DIB00 05050474731660

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female